Manage and deliver full clinical site monitoring services for complex multinational projects, ensuring compliance with SOPs, study guidelines, and GCP best practices.
Act as Lead CRA, serving as primary liaison between CRAs and project teams, and participate in development of monitoring plans, protocols, and tools.
Identify and recruit site investigators, oversee investigational site monitoring, and ensure site staff are compliant with training requirements.
Alimentiv is a clinical research organization providing monitoring and site management services for clinical trials. They are a full-time, permanent employer with a focus on building collaborative relationships and maintaining high standards in clinical study delivery.
Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.
Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.
Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.
Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.
Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.
Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.
Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.
Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.
US Eastern Time ZoneUS Central Time Zone
Unlimited PTO
Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.
CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.
Facilitate negotiations of site agreements and budgets to align with site activation plans.
Customize and prepare country- and site-specific agreements, organizing translations.
Track the status of site agreement and budget negotiation, prepare executable versions, and coordinate the signature process.
PSI is a global company founded in 1995 that brings new medicines to those who need them, working on the front line of medical science. They bring together more than 3,000 driven, dedicated, and passionate individuals who care for staff, clients, partners, and quality of work.
Conduct and report SIV, RMV, COV onsite monitoring visits and perform CRF review, source document verification, and query resolution.
Manage site communication and be the point of contact for in-house support services and vendors, while communicating with internal project teams on study progress.
Support regulatory teams in preparing documents for study submissions and prepare for and participate in audits and inspections.
The company is a dynamic, global mid-size clinical research organization founded in 1995, bringing together more than 3,000 dedicated individuals. They work on the frontline of medical science, changing lives and bringing new medicines to those who need them.